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Use caution Medical device recall · FDA · Published July 20, 2021

Nihon Kohden NKV-550 Ventilator Recall: Defective Gas Regulator May Cause Alarm Failures

Nihon Kohden recalls NKV-550 ventilators with specific serial numbers due to potential gas inlet pressure regulator defects that could cause alarms to fail or gas release noises.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2435-2021Medical deviceNihon Kohden ›
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Contact the company

Recalling firmNIHON KOHDEN ORANGEMED, INC1800 E Wilshire Ave · Santa Ana, CA 92705-4617
✎ GovInfoNow plain-language explainer

Nihon Kohden is recalling NKV-550 ventilators with certain serial numbers because a defective gas inlet pressure regulator might cause alarms to fail or produce gas release noises. This could lead to unsafe oxygen levels for patients using the ventilator. Read more at govinfonow.com/recall/62186-nihon-kohden-nkv-550-ventilator-recall-defective-gas-regulator-may.

Source Summary by GovInfoNow · govinfonow.com/recall/62186-nihon-kohden-nkv-550-ventilator-recall-defective-gas-regulator-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2435-2021

Cite this page

“Nihon Kohden NKV-550 Ventilator Recall: Defective Gas Regulator May Cause Alarm Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62186-nihon-kohden-nkv-550-ventilator-recall-defective-gas-regulator-may. Based on FDA recall #Z-2435-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2435-2021%22&limit=1).

The FDA announced on July 20, 2021, that NIHON KOHDEN ORANGEMED, INC recalled Nihon Kohden NKV-550 Ventilators due to a potential defective gas inlet pressure regulator. The hazard includes gas releasing noise and alarm failures. This Class II recall involved 1,999 units distributed worldwide.

How to tell if you have it

  • Brand: Nihon Kohden
  • Product: NKV-550 Ventilator
  • REF: NKV-550-U
  • CE: 0344
  • UDI: (01) 00843685100012
  • UPC: 00843685100012
  • Serial numbers: NKV5502019xxxx - NKV5502112xxxx, NKV55019270055, NKV55019370098R, NKV55019430125R, NKV55019470156R, NKV55019470160, NKV55020130200, NKV55020140213R, NKV55020140226R, NKV55020140229, NKV55020150241, NKV55020150252, NKV55020160268, NKV55020160276, NKV55020160277, NKV55020160292R, NKV55020160296, NKV55020160297, NKV55020160304, NKV55020160307, NKV55020160308, NKV55020160310, NKV55020160312, NKV55020170317, NKV55020170318, NKV55020170325, NKV55020170335, NKV55020170336, NKV55020170341, NKV55020170342, NKV55020170343, NKV55020170346, NKV55020170347, NKV55020170349, NKV55020170350, NKV55020170352, NKV55020170354, NKV55020170357, NKV55020170360, NKV55020180365, NKV55020180366, NKV55020180369, NKV55020180370, NKV55020180371, NKV55020180372, NKV55020180373, NKV55020180374, NKV55020180375, NKV55020180376, NKV55020180378, NKV55020180379, NKV55020180381, NKV55020180383, NKV55020180384, NKV55020180385, NKV55020180387, NKV55020180391, NKV55020180392, NKV55020180396, NKV55020180397, NKV55020180398, NKV55020180399, NKV55020180400, NKV55020180401, NKV55020180402, NKV55020180403, NKV55020180405, NKV55020180406, NKV55020180408, NKV55020180409, NKV55020180410, NKV55020180411, NKV55020180412, NKV55020180413

The hazard

The ventilator contains a potential defective gas inlet pressure regulator. This defect could result in gas releasing noise from the bottom of the unit, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or failure to pass device Check prior to use.

Context

GovInfoNow's records show other recent recalls of similar products include Draeger Atlan A350 Anesthesia Workstation Recall: Risk of Ventilator Failure (2026-05-07) and Draeger Atlan A350XL Anesthesia Workstation Recall: Risk of Ventilator Failure (2026-05-07). Other recent recalls of similar products include Ventec V+Pro Ventilator Recall: Oxygen Leak Risk (2026-03-25).

How to tell if you have this one

Check the serial number on your ventilator. Affected units have serial numbers between NKV5502019xxxx and NKV5502112xxxx, plus specific listed serial numbers like NKV55019270055 or NKV55020130200.

  • Brand
    Nihon Kohden
  • Product
    Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Identify the serial number on your ventilator to see if it matches the affected range listed in the recall.

  2. Contact Manufacturer

    Reach out to Nihon Kohden for guidance on next steps if your ventilator is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AZ, CA, NY, MA, VT, LA, DC, PA, FL, UT and OUS (countries) of: Brazil, Japan, Ireland, Poland, Scotland, Germany, Kazakhstan, Spain, Slovenia, Germany/Bulgaria, Russia, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, District of Columbia, Florida, Louisiana, Massachusetts, New York, Pennsylvania, Utah, Vermont.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jul 20, 202112. FDA classified it Class II: Sep 8, 202123. Published in FDA’s Enforcement Report: Sep 15, 202134. FDA terminated the recall: Apr 21, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2435-2021 (July 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2435-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA